Acute health event monitoring and alerting

Abstract

A system includes processing circuitry configured to receive a message transmitted from a medical device. The message is indicative of an acute health event of a patient detected by the medical device. The processing circuitry is configured to, in response to the message, determine a location of the patient, generate an alert indicative of the location and the acute health event of the patient, and control transmission of the alert to a response network controller. The response network controller is configured to, in response to the alert, determine a plurality of connected portable treatment devices of a response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices.

Description

ACUTE HEALTH EVENT MONITORING AND ALERTING

[0001] This application claims the benefit of U.S. Provisional Patent Application, Serial No. 63 / 513,771, filed July 14, 2023, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] This disclosure generally relates to systems including medical devices and, more particularly, to monitoring of patient health using such systems.BACKGROUND

[0003] A variety of devices are configured to monitor physiological signals of a patient. Such devices include implantable or wearable medical devices, as well as a variety of wearable health or fitness tracking devices. The physiological signals sensed by such devices include as examples, electrocardiogram (ECG) signals, respiration signals, perfusion signals, activity and / or posture signals, pressure signals, blood oxygen saturation signals, body composition, and blood glucose or other blood constituent signals. Such devices may facilitate monitoring and evaluating patient health in a variety of settings, for example, outside clinical settings, over a period of time, such as days, months or years.

[0004] In some cases, such devices are configured to detect acute health events based on the physiological signals, such as episodes of cardiac arrhythmia, myocardial infarction, stroke, or seizure. Example arrhythmia types include cardiac arrest (e.g., asystole), ventricular tachycardia (VT), and ventricular fibrillation (VF). The devices may store ECG and other physiological signal data collected during a time period including an episode as episode data.

[0005] Acute health events may require rapid response and treatment. For example, VF and other malignant tachyarrhythmias are the most commonly identified arrhythmia in sudden cardiac arrest (SCA) patients. If arrhythmia continues for more than a few seconds, it may result in cardiogenic shock and cessation of effective blood circulation. Thus, reducing wait times for treatment after detecting acute health events may promote positive patient outcomes.SUMMARY

[0006] In general, the present disclosure describes systems and techniques for generating an alert in response to an acute health event of a patient, and transmitting the alert to a response network. The response network may include a response network controller and a population of connected portable treatment devices in communication with the response network controller. In examples, a computing device of the patient, such as a smartphone or smartwatch, receives a message indicating detection of the acute health event transmitted from the medical device, e.g., an implantable medical device. Processing circuitry, e.g., of the computing device, may perform a variety of actions in response to the message, such as analyzing physiological data of the patient to confirm the acute health event, generating an alert, transmitting the alert to the response network controller, and transmitting an alert to family and / or caregivers of the patient. The response network controller may, in turn, determine a plurality of connected portable treatment devices of the response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices. A responder in presence of at least one connected portable treatment device of the plurality of connected portable treatment devices may respond to the treatment request signal by transporting the connected portable treatment device to the patient location, and administer treatment to the patient with the connected portable treatment device. The techniques described herein may reduce the time-to-treatment of the acute health event.

[0007] Additionally, the techniques and systems of this disclosure may be implemented with an implantable medical device (IMD) that may continuously (e.g., on a periodic or triggered basis without human intervention) sense ECG and / or other patient parameter data while subcutaneously implanted in a patient over months or years and perform numerous operations per second on patient parameter data to enable the systems herein to detect acute health events. Using techniques of this disclosure with an IMD may be advantageous when a physician cannot be continuously present with the patient over weeks or months to evaluate the patient parameter data and / or where performing the operations on the ECG and / or other patient parameter described herein (e.g., transmitting an alert to a response network based on the ECG and / or other patient parameters) on weeks or months of data could not practically be performed in the mind of a clinician. Further, the implantable medical device (IMD) may continuously (e.g., on a periodic ortriggered basis without human intervention) determine whether a message indicative of an acute health event of the patient needs to be transmitted to initiate alerting a response network. The implantable medical device (IMD) may substantially instantaneously (e.g., faster than a human) determine an occurrence of an acute health event, generate the message indicative of the acute health event, and transmit the message to initiate alerting the response network.

[0008] In examples, a system includes processing circuitry and memory comprising program instructions. The program instructions, when executed by the processing circuitry, cause the processing circuitry to receive a message transmitted from a medical device. The message is indicative of an acute health event of a patient detected by the medical device. The program instructions may further cause the processing circuitry to, in response to the message, determine a location of the patient, generate an alert indicative of the location and the acute health event of the patient, and control transmission of the alert to a response network controller. The response network controller is configured to, in response to the alert, determine a plurality of connected portable treatment devices of a response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices.

[0009] In examples, a method includes by processing circuitry, receiving a message transmitted from a medical device. The message is indicative of an acute health event of a patient detected by the medical device. The method may further include, by the processing circuitry, in response to the message: determining a location of the patient, generating an alert indicative of the location and the acute health event of the patient, and controlling transmission of the alert to a response network controller. The response network controller is configured to, in response to the alert, determine a plurality of connected portable treatment devices of a response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices.

[0010] In examples, a system includes processing circuitry configured to perform any of the methods described herein.

[0011] In examples, a non-transitory computer readable storage medium includes program instructions configured to cause processing circuitry to perform any of the methods described herein.

[0012] The details of one or more examples of the techniques of this disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0013] FIGS. 1A and IB are block diagrams illustrating an example medical device system configured to detect acute health events, and to respond to such detections, in accordance with one or more techniques of this disclosure.

[0014] FIG. 2 is a block diagram illustrating an example configuration of the IMD of FIG. 1A.

[0015] FIG. 3 is a conceptual side-view diagram illustrating an example configuration of the IMD of FIGS. 1A and 2.

[0016] FIG. 4 is a block diagram illustrating an example configuration of a computing device that operates in accordance with one or more techniques of the present disclosure.

[0017] FIG. 5 is a block diagram illustrating an example configuration of a computing system that operates in accordance with one or more techniques of the present disclosure.

[0018] FIG. 6 is a flow diagram illustrating an example technique for providing alerts in response to detection of an acute health event of a patient.

[0019] FIG. 7 is a flow diagram illustrating an example technique for transmitting an alert to potential responders within an alert area.

[0020] FIG. 8A is a perspective drawing illustrating an insertable cardiac monitor.

[0021] FIG. 8B is a perspective drawing illustrating another insertable cardiac monitor.

[0022] Like reference characters refer to like elements throughout the figures and description.DETAILED DESCRIPTION

[0023] The present disclosure describes systems and techniques for generating an alert in response to an acute health event of a patient, and transmitting the alert to a response network. The response network may include a plurality of connected portable treatment devices. A responder may transport a connected portable treatment device to a location ofthe patient in response to the alert, and administer treatment to the patient using the connected portable treatment device. Thus, systems and techniques according to the present disclosure may elicit timely response to and treatment of the acute health event of the patient.

[0024] A variety of types of implantable and medical devices detect arrhythmia episodes and other acute health events based on sensed ECGs and, in some cases, other physiological signals. External devices that may be used to non-invasively sense and monitor ECGs and other physiological signals include wearable devices with electrodes configured to contact the skin of the patient, such as patches, watches, or necklaces. Such external devices may facilitate relatively longer-term monitoring of patient health during normal daily activities.

[0025] Implantable medical devices (IMDs) also sense and monitor ECGs and other physiological signals, and detect acute health events such as episodes of arrhythmia, cardiac arrest, myocardial infarction, stroke, and seizure. Example IMDs include pacemakers and implantable cardioverter-defibrillators, which may be coupled to intravascular or extravascular leads, as well as pacemakers with housings configured for implantation within the heart, which may be leadless. Some IMDs do not provide therapy, such as implantable patient monitors. One example of such an IMD is the Reveal LINQ™ or LINQ II™ Insertable Cardiac Monitor (ICM), available from Medtronic, Inc., which may be inserted subcutaneously. Such IMDs may facilitate relatively longer-term monitoring of patients during normal daily activities, and may periodically transmit collected data, e.g., episode data for detected arrhythmia episodes, to a remote patient monitoring system, such as the Medtronic Carelink™ Network.

[0026] FIGS. 1A and IB are block diagrams illustrating an example medical device system 2 configured to detect and respond to acute health events of a patient 4, in accordance with the techniques of the disclosure. The example techniques may be used with a medical device 10, which may be in wireless communication with at least one external computing devices, e.g., computing devices 12A and 12B (collectively “at least one computing device 12”). In some examples, medical device 10 is an IMD (also referred to as “IMD 10”). In some examples, IMD 10 is implanted outside of a thoracic cavity of patient 4 (e.g., subcutaneously in the pectoral location illustrated in FIG. 1). IMD 10 may be positioned near the sternum near or just below the level of the heart ofpatient 4, e.g., at least partially within the cardiac silhouette. IMD 10 includes a plurality of electrodes (not shown in FIG. 1), and is configured to sense an ECG via the plurality of electrodes. In some examples, IMD 10 takes the form of a LINQ™ ICM. Although described primarily in the context of examples in which the IMD takes the form of an ICM, the techniques of this disclosure may be implemented in systems including any one or more implantable or external medical devices, including monitors, pacemakers, defibrillators, or neurostimulators.

[0027] At least one computing device 12 is configured for wireless communication with IMD 10. At least one computing device 12 retrieves episode and other physiological data from IMD 10 that was collected and stored by IMD 10. In some examples, at least one computing device 12 takes the form of personal computing devices of patient 4. For example, computing device 12A may take the form of a smartphone of patient 4, and computing device 12B may take the form of a smartwatch or other smart apparel of patient 4. In some examples, at least one computing devices 12 may be any computing device configured for wireless communication with IMD 10, such as a desktop, laptop, or tablet computer, a smart home controller, alarm, thermostat, speaker, or other smart appliance, or any Internet of Things (loT) device. At least one computing device 12 may communicate with IMD 10 and each other according to the Bluetooth® or Bluetooth® Low Energy (BLE) protocols, as examples. In some examples, only one of a plurality of computing devices 12, e.g., computing device 12A, is configured for communication with IMD 10, e.g., due to execution of software enabling communication and interaction with IMD 10.

[0028] In some examples, at least one computing device 12, e.g., wearable computing device 12B in the example illustrated by FIG. 1A, may include electrodes and other sensors to sense physiological signals of patient 4, and may collect and store physiological data and detect episodes based on such signals. Computing device 12B may be incorporated into the apparel of patient 4, such as within clothing, shoes, eyeglasses, a watch or wristband, a hat, etc. In some examples, computing device 12B is a smartwatch or other accessory or peripheral for a smartphone computing device 12 A.

[0029] At least one computing device 12 may be configured to communicate with a variety of other devices or systems via a network 16. At least one computing device 12 may transmit data, including data retrieved from IMD 10, to other devices or systems via network 16. The data may include values of physiological parameters measured by IMD10 and, in some cases at least one computing device 12, data regarding episodes of arrhythmia or other health events detected by IMD 10 and at least one computing device 12, and other physiological signals or data recorded by IMD 10 and / or at least one computing device 12. In some examples, system 2 may not include an IMD 10, and instead, include an external or wearable medical device. In some such examples, at least one computing device 12 may monitor one or more physiological signals of patient 4.

[0030] One or more components of system 2 may be configured to be in communication with a response network 14, for example, via network 16. As described elsewhere in the disclosure, response network 14 includes a response network controller and a plurality of connected portable treatment devices.

[0031] System 2 may further include at least one computing device 18, associated with a user predetermined to be responders or caregivers either for patient 4 or the acute health event experienced by patient, such as treating clinicians, family members, first responders, or other caregivers.

[0032] System 2 may further include a computing system 20. Computing system 20 may include at least one computing device configured to allow users, e.g., clinicians treating patient 4 (and other patients) to interact with data collected from IMD 10 and at least one computing device 12 of patient 4 (or other medical devices or computing devices). In some examples, computing system 20 includes one or more handheld computing devices, computer workstations, servers, a cloud computing system, or other networked computing devices. Computing system 20 may comprise, or may be implemented by, the Medtronic Carelink™ Network, in some examples.

[0033] One or more components of system 2 may be configured to be in communication with an emergency medical system (EMS) 22, for example, via network 16, or via response network 14. EMS 22 may be in communication with at least one emergency service provider or a first responder, for example, a police station, a fire station, a paramedic facility, a hospital, a dispatcher, or any other suitable emergency service provider.

[0034] Network 16 may include one or more computing devices (not shown), such as one or more non-edge switches, routers, controllers, gateways, security devices such as firewalls, intrusion detection, and / or intrusion prevention devices, servers, cellular base stations and nodes, wireless access points, bridges, cable modems, applicationaccelerators, or other network devices. Network 16 may include one or more networks administered by service providers, and may thus form part of a large-scale public network infrastructure, e.g., the Internet. Network 16 may provide computing devices, such as at least one computing device 12, response network 14, at least one computing device 18, computing system 20, or EMS 22, access to the Internet, and may provide a communication framework that allows the computing devices to communicate with one another.

[0035] In some examples, network 16 includes a private network that provides a communication framework that allows at least one computing device 12 to communicate with computing system 20 and / or other systems or devices, but isolates one or more of these devices or data flows between these devices from devices external to the private network for security purposes. In some examples, the communications between at least one computing device 12 and other devices, such as devices of computing system 20, are encrypted.

[0036] Response network 14 may include a response network controller 24 in communication with a plurality of connected portable treatment devices 26A to 26N (collectively, “connected portable treatment devices 26”). Response network controller 24 includes memory and processing circuitry configured to execute program instructions stored in the memory. For example, response network controller 24 may be configured to transmit control signals or alerts to the plurality of connected portable treatment devices 26.

[0037] Each device of the plurality of connected portable treatment devices 26 is configured to communicate, for example, wirelessly, with each other and / or with response network controller 24. Each device of the plurality of connected portable treatment devices 26 is configured to output, via at least one output device, a signal to a responder. In some examples, each device of the plurality of connected portable treatment devices 26 includes a display configured to display a visual message, and a speaker configured to output an audio alert.

[0038] Each device of the plurality of connected portable treatment devices 26 is configured to treat at least one acute health event. In some examples, at least one device of plurality of connected portable treatment devices 26 is configured to treat the acute health event detected in patient 4. In some examples, at least one device of the plurality ofconnected portable treatment devices 26 includes an automated external defibrillator (AED).

[0039] Each device of the plurality of connected portable treatment devices 26 is transportable, for example, to a location of patient 4. For example, each device of the plurality of connected portable treatment devices 26 may be dimensioned, proportioned, weighted, or otherwise configured to be transported by hand, carried on a person, or transported in a vehicle, to the location of patient 4. In some examples, each device of the plurality of connected portable treatment devices 26 includes a respective handle.

[0040] Each device of the plurality of connected portable treatment devices 26 is configured to receive a treatment request signal, for example, from response network controller 24, and display an alert (for example, an audiovisual alert) indicative of the treatment request signal. For example, the alert may be indicative of the location of patient 4 and the nature of the acute health event. A responder in presence of a respective device of plurality of connected portable treatment devices 26 may, in response to the alert, transport the respective device to a location of patient 4, and deploy the respective device to administer treatment (for example, an AED to deliver defibrillation therapy) to mitigate the acute health event.

[0041] Processing circuitry of system 2, e.g., processing circuitry of one or more of computing device 12A, computing device 12B, and computing system 20, alone or in any combination, may implement the techniques of this disclosure for responding to detection of an acute health event of patient 4 by medical device 10. The processing circuitry may receive a message transmitted from medical device 10, for example, an implantable medical device or an external medical device. The message is indicative of an acute health event of patient 4 detected by medical device 10.

[0042] The message may indicate that medical device 10 detected an acute health event of the patient. The message may indicate a time that medical device 10 detected the acute health event. The message may include physiological data collected by medical device 10, e.g., data which lead to detection of the acute health event, data prior to detection of the acute health event, and / or real-time or more recent data collected after detection of the acute health event. The physiological data may include values of one or more physiological parameters and / or digitized physiological signals. Examples of acutehealth events are a cardiac arrest, a ventricular fibrillation, a ventricular tachycardia, a stroke, a seizure, or a fall.

[0043] The processing circuitry may provide alerts in response to the detection of the acute health event. For example, the processing circuitry may be configured to, in response to the message, determine a location of patient 4, generate an alert indicative of the location and the acute health event of the patient, and control transmission of the alert to response network controller 24.

[0044] Response network controller 24 may be configured to, in response to the alert, determine plurality of connected portable treatment devices 26 of response network 14 based on the location and transmit a treatment request signal to plurality of connected portable treatment devices 26. For example, response network controller 24 may determine an alert area 28 based on the location of patient 4, select a plurality of connected portable treatment devices 26 presently located within alert area 28. In other examples, the processing circuitry may determine alert area 28 based on the location of patient 4. Alternatively, the processing circuitry may determine a candidate response area based on the location of the patient, and the alert may be indicative of the candidate response area. Response network controller 24 may or may not adopt or modify the candidate response area as alert area 28.

[0045] Plurality of connected portable treatment devices 26 are devices of one or more potential responders that may be able to provide aid to patient 4 by transporting a device to patient 4 within alert area 28 and, thus, sufficiently proximate to the location of patient 4. The potential responders are not necessarily known in advance to be potential responders or caregivers either for patient 4 or the acute health event experienced by patient 4. Response network controller 24 may transmit an alert to connected portable treatment devices 26 that are within alert area 28, which may present the alert to responders generally near patient 4. Response network controller 24 (or the processing circuitry) may similarly provide an alert to one or more computing devices 18, that are not necessarily within alert area 28.

[0046] The alert may provide a variety of information to assist the responders in responding to the acute health event for patient 4. For example, the alert may include the name or type of acute health event, at least one of an onset time of the acute health event or an elapsed time of the acute health event, and / or at least a portion of the physiologicaldata of patient 4 received in the message from medical device 10. In some examples, the alert may further include instructions for finding or gaining access to the patient’s residence. For example, the alert may include local directions or patient access information including one or more of an apartment number, a floor number, an office number, a suite number, an external or internal landmark (for example, orientation or location of an apartment or residence relative to an elevator door, staircase, or a main entryway or hallway), a building entry code, a residential door entry code, an apartment entry code, a garage entry code, a residential phone number, an office phone number, or an emergency contact number.

[0047] The alert may include the location of patient 4. In some examples, the alert may cause or enable response network controller 24 to provide the responder directions to the location of patient 4, for example, via an output of a respective device of connected portable treatment devices 26.

[0048] In some examples, the alert includes treatment instructions for the health event, e.g., cardiopulmonary resuscitation (CPR) instructions. In some examples, the processing circuitry selects treatment instructions to include in the alert based on the acute health event and / or the physiological data included in the message from medical device 10. In some examples, the treatment instructions may include the local directions or patient access information.

[0049] In some examples, in addition to the transmitted alerts, the processing circuitry may cause one or more computing devices 12 of patient 4 to provide an alert via their user interfaces. Such local alerts may be the same as or different than the transmitted alerts. The local alerts may be configured, e.g., audibly and / or visually, to attract the attention of patient 4 and / or any persons in close proximity to patient 4.

[0050] In some examples, the alert is further indicative of a presence of a connected portable treatment device of the plurality of connected portable treatment devices 26 at the location of patient 4. For example, patient 4, or a room-mate, a family member, or caregiver at the same location as patient 4, may be in possession of a connected portable treatment device. In some examples, a neighbor of patient 4 may in possession of a connected portable treatment device. In some such examples, a responder may not need to transport an additional connected portable treatment device, and may instead, or in addition, use the connected portable treatment device at the location of patient 4.

[0051] In some examples, patient 4 or a nearby caregiver may be able to provide alert cancellation input via the user interface of one or more computing devices 12. The processing circuitry may suspend or terminate the local alert in response to a cancellation. The processing circuitry may determine whether to transmit other alerts or take other actions therein based on not receiving a cancellation within a time interval from initiation of the local alert. In some examples, instead of or in addition to the transmitted alerts, the processing circuitry is configured to control a computing device 12 to place a telephonic call to EMS 22, e.g., to autodial 911. The call may be cancelled by patient 4 or a nearby caregiver via a user interface of the computing device 12. In some examples, response network controller 24, or a device of the plurality of connected portable treatment devices 26, is configured to send a signal to EMS 22 to initiate communication with one or more emergency service providers.

[0052] In some examples, the processing circuitry is configured to control transmission of a cessation signal to response network controller 24. The cessation signal may be indicative of at least one of a confirmation of a response to the acute health event, a termination of the acute health event, or a retraction of the acute health event. For example, if a responder successfully arrives at the location of patient 4, or further successfully deploys a respective connected portable treatment device, the processing circuitry may transmit the cessation signal indicative of confirmation of a response to the acute health event. As another example, if the acute health event naturally reduces in intensity or frequency without external intervention, the patient or a responder may choose to terminate a request for response. In such examples, a party may cause the processing circuitry to transmit the cessation signal indicative of confirmation of a response to the acute health event. If the patient, a responder, or another party determines that the alert was sent in error, or that a sufficient response to the acute health event has otherwise been received, a party may cause the processing circuitry to transmit a cessation signal indicative of retraction of the acute health event.

[0053] In some examples, the processing circuitry is configured to perform an analysis to confirm the acute health event, and may deliver or withhold alerts and / or calls based on the analysis. The analysis may be of the physiological data received from IMD 10 and / or physiological data collected by a computing device 12 of patient 4, e.g., computing device 12B. In some examples, the processing circuitry, e.g., of computing devices 12 and / orcomputing system 20, may have greater processing capacity than medical device 10, enabling more complex analysis of physiological data. In some examples, the processing circuitry may apply the physiological data to a machine learning model or other artificial intelligence, e.g., to determine whether the physiological data is sufficiently indicative of the acute health event.

[0054] Although described herein in the context of example medical device 10, the techniques for cardiac arrhythmia detection disclosed herein may be used with other types of devices. For example, the techniques may be implemented with an extra-cardiac defibrillator coupled to electrodes outside of the cardiovascular system, a transcatheter pacemaker configured for implantation within the heart, such as the Micra™ transcatheter pacing system commercially available from Medtronic, Inc., a neurostimulator, or a drug delivery device.

[0055] FIG. 2 is a block diagram illustrating an example configuration of IMD 10 of FIG. 1A. As shown in FIG. 2, IMD 10 includes processing circuitry 50, sensing circuitry 52, communication circuitry 54, memory 56, sensors 58, switching circuitry 60, and electrodes 16A, 16B (hereinafter “electrodes 16”), one or more of which may be disposed on a housing of IMD 10. In some examples, memory 56 includes computer-readable instructions that, when executed by processing circuitry 50, cause IMD 10 and processing circuitry 50 to perform various functions attributed herein to IMD 10 and processing circuitry 50. Memory 56 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random-access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media.

[0056] Processing circuitry 50 may include fixed function circuitry and / or programmable processing circuitry. Processing circuitry 50 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry. In some examples, processing circuitry 50 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processing circuitry 50 herein may be embodied as software, firmware, hardware, or any combination thereof.

[0057] Sensing circuitry 52 may be selectively coupled to electrodes 32A, 32B (collectively, “electrodes 32”) via switching circuitry 60 as controlled by processing circuitry 50. Sensing circuitry 52 may monitor signals from electrodes 32A, 32B in order to monitor electrical activity of a heart of patient 4 of FIG. 1 A and produce ECG data for patient 4. In some examples, processing circuitry 50 may identify features of the sensed ECG, such as heart rate, heart rate variability, intra-beat intervals, and / or ECG morphologic features, to detect an episode of cardiac arrhythmia of patient 4. Processing circuitry 50 may store the digitized ECG and features of the ECG used to detect the arrhythmia episode in memory 56 as episode data for the detected arrhythmia episode.

[0058] In some examples, sensing circuitry 52 measures impedance, e.g., of tissue proximate to IMD 10, via electrodes 32. The measured impedance may vary based on respiration and a degree of perfusion or edema. Processing circuitry 50 may determine physiological data relating to respiration, perfusion, and / or edema based on the measured impedance.

[0059] In some examples, IMD 10 includes one or more sensors 58, such as one or more accelerometers, microphones, optical sensors, temperature sensors, and / or pressure sensors. In some examples, sensing circuitry 52 may include one or more filters and amplifiers for filtering and amplifying signals received from one or more of electrodes 32 and / or other sensors 58. In some examples, sensing circuitry 52 and / or processing circuitry 50 may include a rectifier, filter and / or amplifier, a sense amplifier, comparator, and / or analog-to-digital converter. Processing circuitry 50 may determine physiological data, e.g., values of physiological parameters of patient 4, based on signals from sensors 58, which may be stored in memory 56.

[0060] Processing circuitry 50 may detect an acute health event of patient 4 based on combination of one or more of the types of physiological data described herein. For example, processing circuitry 50 may detect a cardiac arrest, a ventricular fibrillation, a ventricular tachycardia, or a myocardial infarction based on an ECG and / or other physiological data indicating the electrical or mechanical activity of heart 6 of patient 4 (FIG. 1A). In some examples, processing circuitry 50 may detect stroke based on such cardiac activity data. In some examples, sensing circuitry 52 may detect brain activity data, e.g., an electroencephalogram (EEG) via electrodes 32, and processing circuitry 50 may detect stroke or a seizure based on the brain activity alone, or in combination withcardiac activity data or other physiological data. In some examples, processing circuitry 50 detects whether the patient has fallen based on data from an accelerometer alone, or in combination with other physiological data.

[0061] In some examples, processing circuitry 50 transmits, via communication circuitry 54, the physiological data for an episode to at least one computing device 12 (FIG. IB). Such transmissions may occur on a daily or other basis. In some examples, when the episode is an acute health event, processing circuitry 50 transmits to at least one computing devices 12, via communication circuitry 54, a message indicating the acute health event, as described herein. Transmission of the message may occur on an ad hoc basis and as quickly as possible. Communication circuitry 54 may include any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as computing devices 12, with the aid of an internal or external antenna, e.g., antenna 30.

[0062] FIG. 3 is a conceptual side-view diagram illustrating an example configuration of IMD 10. In the example shown in FIG. 3, IMD 10 may include a leadless, subcutaneously-implantable monitoring device having a housing 72 and an insulative cover 74. Electrode 32 may be formed or placed on an outer surface of cover 74. Circuitries 50-56 and 60, described above with respect to FIG. 2, may be formed or placed on an inner surface of cover 74, or within housing 72. In the illustrated example, antenna 30 is formed or placed on the inner surface of cover 74, but may be formed or placed on the outer surface in some examples. Sensors 58 may also be formed or placed on the inner or outer surface of cover 74 in some examples. In some examples, insulative cover 74 may be positioned over an open housing 18 such that housing 72 and cover 74 enclose antenna 30, sensors 58, and circuitries 50-56 and 60, and protect the antenna and circuitries from fluids such as body fluids.

[0063] One or more of antenna 30, sensors 58, or circuitries 50-56 may be formed on insulative cover 74, such as by using flip-chip technology. Insulative cover 74 may be flipped onto a housing 72. When flipped and placed onto housing 72, the components of IMD 10 formed on the inner side of insulative cover 74 may be positioned in a gap 76 defined by housing 72. Electrodes 32 may be electrically connected to switching circuitry 60 through one or more vias (not shown) formed through insulative cover 74. Insulative cover 74 may be formed of sapphire (i.e., corundum), glass, parylene, and / or any othersuitable insulating material. Housing 72 may be formed from titanium or any other suitable material (e.g., a biocompatible material). Electrodes 32 may be formed from any of stainless steel, titanium, platinum, iridium, or alloys thereof. In addition, electrodes 32 may be coated with a material such as titanium nitride or fractal titanium nitride, although other suitable materials and coatings for such electrodes may be used.

[0064] FIG. 4 is a block diagram illustrating an example configuration of at least one computing device 12 of patient 4, which may correspond to either (or both operating in coordination) of computing devices 12A and 12B illustrated in FIG. 1A. In some examples, at least one computing device 12 takes the form of a smartphone, a laptop, a tablet computer, a personal digital assistant (PDA), a smartwatch or other wearable computing device, smart home appliance, such as a smart speaker, or any loT device. As shown in the example of FIG. 4, computing device 12 includes processing circuitry 80, storage device 82, communication circuitry 84, a user interface 86 and, in some examples, one or more sensors 88. Although shown in FIG. 4 as a stand-alone device for purposes of example, at least one computing device 12 may be any component or system that includes processing circuitry or other suitable computing environment for executing software instructions and, for example, need not necessarily include one or more elements shown in FIG. 4 (e.g., in some examples components such as storage device 82 may not be colocated or in the same chassis as other components).

[0065] Processing circuitry 80, in one example, is configured to implement functionality and / or process instructions for execution within at least one computing device 12. For example, processing circuitry 80 may be capable of processing instructions, including at least one application 90, stored in storage device 82. Examples of processing circuitry 80 may include, any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field- programmable gate array (FPGA), or equivalent discrete or integrated logic circuitry.

[0066] Storage device 82 may be configured to store information within computing device 12, including at least one application 90 and data 100. Storage device 82, in some examples, is described as a computer-readable storage medium. In some examples, storage device 82 includes a temporary memory or a volatile memory. Examples of volatile memories include random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), and other forms of volatilememories known in the art. Storage device 82, in one example, is used by at least one application 90 running on at least one computing device 12 to temporarily store information during program execution. Storage device 82, in some examples, also includes one or more memories configured for long-term storage of information, e.g., including non-volatile storage elements. Examples of such non-volatile storage elements include magnetic hard discs, optical discs, floppy discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable (EEPROM) memories.

[0067] At least one computing device 12 utilizes communication circuitry 84 to communicate with other devices, such as medical device 10, other computing devices 12, and computing system 20 of FIG. IB. Communication circuitry 84 may include a network interface card, such as an Ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device that can send and receive information. Other examples of such network interfaces may include 3G, 4G, 5G, and WiFi radios.

[0068] Computing device 12 also includes a user interface 86. User interface 86 may be configured to provide output to a user using tactile, audio, or video stimuli and receive input from a user through tactile, audio, or video feedback. User interface 86 may include, as examples, a presence- sensitive display, a mouse, a keyboard, a voice responsive system, video camera, microphone, or any other type of device for detecting a command from a user, a sound card, a video graphics adapter card, or any other type of device for converting a signal into an appropriate form understandable to humans or machines, a speaker, a cathode ray tube (CRT) monitor, a liquid crystal display (LCD), or any other type of device that can generate intelligible output to a user. In some examples, a presence- sensitive display includes a touch-sensitive screen.

[0069] At least one application 90 executable by processing circuitry 80 of computing device 12 may include an IMD interface application 92, a monitoring system 94 that may utilize one or more machine learning models 96, and a location service 98. Execution of IMD interface 92 by processing circuitry 80 configures computing device 12 to interface with medical device 10. For example, IMD interface 92 configures computing device 12 to communicate with medical device 10 via communication circuitry 84. Processing circuitry 80 may receive physiological data of patient 4 from medical device 10, and store the physiological data as medical data 102 in memory 82. In some examples, processingcircuitry 80 receives physiological data from medical device 10 with a message indicating an acute health event. IMD interface 92 also configures user interface 86 for a user to interact with medical device 10 and / or medical data 102.

[0070] Processing circuitry 80 may execute monitoring system 94 to facilitate monitoring the health of patient 4, e.g., based on medical data 102 received from IMD 10 and / or data computing device data 104 collected by computing device 12. Monitoring system 94 may cause processing circuity 80 and computing device 12 to perform any of the techniques described herein related to responding to detection of an acute health event by medical device 10.

[0071] Processing circuitry 80 may execute location service 98 to determine the location of at least one computing device 12 and, thereby, the presumed location of patient 4. Processing circuitry 80 may use global position system (GPS) data, multilateration, and / or any other known techniques for locating computing devices. In some examples, monitoring system 94 may use the location of patient 4 and geofence data 106 to determine alert area 28 as a geofence. Geofence data 106 may include different geofence distances from patient for different acute health events or different patient locations with different expected population densities, and monitoring system 94 may select a geofence distance based on such parameters.

[0072] In some examples, as illustrated in FIG. 4, computing device may include at least one sensor 88 for sensing physiological parameters or signals of patient 4. At least one sensor 88 may include electrodes and other sensors, and sensing circuitry (e.g., including an ADC), as described above with respect to medical device 10 and FIG. 2. Processing circuitry 80 may store physiological data from sensors 88 as computing device data 104 in storage device 82.

[0073] As examples, computing device data 104 may include one or more of: activity levels, walking / running distance, resting energy, active energy, exercise minutes, quantifications of standing, body mass, body mass index, heart rate, low, high, and / or irregular heart rate events, heart rate variability, walking heart rate, heart beat series, digitized ECG, blood oxygen saturation, blood pressure (systolic and / or diastolic), respiratory rate, maximum volume of oxygen, blood glucose, peripheral perfusion, and sleep patterns.

[0074] Processing circuitry 80 may also receive user recorded health data via user interface 86 and store such data as computing device data 104. User recorded health data may include one or more of: exercise and activity data, sleep data, symptom data, medical history data, quality of life data, nutrition data, medication taking or compliance data, allergy data, demographic data, weight, and height. Medical history data may relate to history of cardiac arrest, tachyarrhythmia, myocardial infarction, stroke, seizure, chronic obstructive pulmonary disease (COPD), renal dysfunction, or hypertension, history of procedures, such as ablation or cardioversion, and healthcare utilization.

[0075] In some examples, processing circuitry 80 executes monitoring system 94 to perform an analysis to confirm an acute health event detected by medical device 10, and delivers or withhold alerts and / or calls based on the analysis. The analysis may be of medical data 102 and / or computing device data 104. In some examples, monitoring system 94 applies the data to at least one machine learning model 96, other artificial intelligence, or other models or algorithms that do not necessarily require machine learning, such as linear regression, trend analysis, decision trees, or thresholds, to determine whether the data is sufficiently indicative of the acute health event to confirm its occurrence.

[0076] FIG. 5 is a block diagram illustrating an example configuration of computing system 20. Computing system 20 may be any component or system that includes processing circuitry or other suitable computing environment for executing software instructions and, for example, need not necessarily include one or more elements shown in FIG. 5 (e.g., user interface devices 204, communication circuitry 206; and in some examples components such as at least one storage device 208 may not be co-located or in the same chassis as other components). In some examples, computing system 20 may be a cloud computing system distributed across a plurality of devices.

[0077] In the example of FIG. 5, computing system 24 includes processing circuitry 202, at least one user interface (UI) device 204, communication circuitry 206, and at least one storage device 208. Computing system 20, in some examples, further includes at least one application 220 such as monitoring system 222, that are executable by computing system 20.

[0078] Processing circuitry 202, in one example, is configured to implement functionality and / or process instructions for execution within computing system 20. Forexample, processing circuitry 202 may be capable of processing instructions stored in storage device 208. Examples of processing circuitry 202 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or integrated logic circuitry.

[0079] At least one storage device 208 may be configured to store information within computing device 20 during operation. At least one storage device 208, in some examples, is a computer-readable storage medium. In some examples, at least one storage device 208 is a temporary memory, meaning that a primary purpose of at least one storage device 208 is not long-term storage. In some examples, at least one storage device 208 is a volatile memory, meaning that at least one storage device 208 does not maintain stored contents when the computer is turned off. Examples of volatile memories include random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), and other forms of volatile memories known in the art. In some examples, at least one storage device 208 is used by software or at least one application 220 running on computing system 20 to temporarily store information during program execution.

[0080] At least one storage device 208 may further be configured for long-term storage of information, such as at least one application 220 and data 230. In some examples, at least one storage device 208 includes non-volatile storage elements. Examples of such non-volatile storage elements include magnetic hard discs, optical discs, floppy discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable memories (EEPROM).

[0081] Computing system 20, in some examples, also includes communication circuitry 206 to communicate with other devices and systems, such as computing devices 12 of FIGS. 1A and IB. Communication circuitry 206 may include a network interface card, such as an Ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device that can send and receive information. Other examples of such network interfaces may include 3G, 4G, 5G, and WiFi radios.

[0082] Computing system 20, in one example, also includes at least one interface device 204. At least one user interface device 204, in some examples, may be configured to provide output to a user using tactile, audio, or video stimuli and receive input from auser through tactile, audio, or video feedback. At least one user interface device 204 may include, as examples, a presence-sensitive display, a mouse, a keyboard, a voice responsive system, video camera, microphone, or any other type of device for detecting a command from a user, a sound card, a video graphics adapter card, or any other type of device for converting a signal into an appropriate form understandable to humans or machines, a speaker, a cathode ray tube (CRT) monitor, a liquid crystal display (LCD), or any other type of device that can generate intelligible output to a user.

[0083] At least one application 220 may include program instructions and / or data that are executable by processing circuitry 202 of computing system 20 to cause computing system 20 to provide the functionality ascribed to it herein. Example at least one application 220 may include monitoring system 222. Other additional applications not shown may alternatively or additionally be included to provide other functionality described herein and are not depicted for the sake of simplicity.

[0084] In accordance with the techniques of the disclosure, computing system 20 receives medical data 102 and computing device data 104 from computing device 12 via communication circuitry 206. Computing system 20 may also receive location data 232 indicating a location of patient 4 from computing device 12 via communication circuitry 206. Processing circuitry 202 stores these, as well as (optionally) geofence data 106, as data 230 in storage devices 208. Processing circuitry 202 may execute monitoring system 222. Monitoring system 222 may be the same as monitoring system 94 of computing device 12, e.g., computing device 12 may primarily relay messages and data to computing system 20 for performance of the techniques described herein, or may operate in combination with monitoring system 94 to facilitate any of the functionality described herein.

[0085] FIG. 6 is a flow diagram illustrating an example technique for providing alerts in response to detection of an acute health event of a patient. The example technique of FIG. 6 is described as being implemented by processing circuitry 80 of computing device 12, e.g., implementing monitoring system 94. In some examples, processing circuitry 202 of computing system 20 may implement monitoring system 222 to perform some or all of the functions of the example technique.

[0086] According to the example illustrated by FIG. 6, processing circuitry 80 receives a message transmitted from medical device 10 indicating that patient 4 has experienced anacute health event (300). The message may be wirelessly transmitted. Processing circuitry 80 analyzes physiological data in response to the message (302). The physiological data may include medical data 102 received from medical device 10, e.g., as part of the message, and / or computing device data 104. Computing device data 104 may be sensed by the computing device executing the example technique if the computing device is configured to do so, or by another computing device 12. For example, computing device 12A of FIG. 1A, e.g., a smartphone, may implement the example technique of FIG. 6, and receive computing device data 104 from computing device 12B, e.g., a smartwatch or other wearable sensing and computing device. The analysis may include application of the physiological data to a machine learning model, other artificial intelligence, or other models or algorithms that do not necessarily require machine learning, such as linear regression, trend analysis, decision trees, or thresholds.

[0087] If processing circuitry 80 determines that the acute health event is not confirmed by the analysis (NO of 304), the example technique may end. If processing circuitry 80 determines that the acute health event is confirmed by the analysis (YES of 304), processing circuitry 80 may present a local alert via user interface 86 of computing device 12 (306). Processing circuitry 80 may start a timer. Processing circuitry 80 may determine whether user input cancelling the alert is received via user interface within a predetermined time interval from initiation of the alert (308). If processing circuitry 80 determines that the alert cancellation input is received within the predetermined time interval (YES of 308), the local alert may be stopped and the example technique may end. If processing circuitry 80 determines that the alert cancellation input is not received within the predetermined time interval (NO of 308), processing circuitry 80 may transmit an external alert and / or take any other actions described herein. For example, processing circuitry 80 may transmit an alert to response network 14 (or to response network controller 24), and to one or more computing devices 18 of family or caregivers of patient 4 (310).

[0088] FIG. 7 is a flow diagram illustrating an example technique for transmitting an alert to connected portable treatment devices 26 of potential responders within alert area 28. According to the example illustrated by FIG. 7, processing circuitry 80 of computing device 12 receives a message transmitted from medical device 10 indicating that patient 4has experienced an acute health event (400). In response to the message, processing circuitry 80 determines a location of patient 4, e.g., by executing location service 98 (402).

[0089] Processing circuitry 80 of computing device 12 and / or processing circuitry 202 of computing system 20 may optionally determine a candidate response area based on the location of patient 4 (404). In other examples, response network controller 24 determines alert area 28 (404).

[0090] Processing circuitry 80 and / or processing circuitry 202 generates an alert. The alert is indicative of the location and the acute health event of patient 4. In some examples, processing circuitry 80 and / or processing circuitry 202 generate treatment instructions based on the acute health event, with the alert being further indicative of the treatment instructions. In some examples, the alert is further indicative of a presence of a connected portable treatment device of the plurality of connected portable treatment devices 26 at the location of patient 4.

[0091] In some examples, processing circuitry 80 and / or processing circuitry 202 controls transmission of the alert to response network 14 (or to response network controller 24) (406). As discussed elsewhere in the disclosure, response network controller 24 is configured to, in response to the alert, determine a plurality of connected portable treatment devices 26 of response network 14 based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices 26.

[0092] If processing circuitry 80 and / or processing circuitry 202 determines that the acute health event has been terminated or retracted (YES of 408), processing circuitry 80 and / or processing circuitry 202 may further control transmission of a cessation signal to response network 14 (or to response network controller 24) (414). The cessation signal may be indicative of at least one of a confirmation of a response to the acute health event, a termination of the acute health event, or a retraction of the acute health event. If processing circuitry 80 and / or processing circuitry 202 determines that the acute health event has not been terminated or retracted (NO of 408), no cessation signal is sent.

[0093] The technique of FIG. 7 may further include, in response to the treatment request signal, transporting at least one connected portable treatment device of the plurality of connected portable treatment devices 26 to the location of patient 4 and administering treatment to the patient 4 with the at least one connected portable treatment device (410). For example, a responder in proximity to at least one device of the pluralityof connected portable treatment devices 26 may transport the at least one device to the location of patient 4, and deploy the at least one device to treat patient 4.

[0094] The responder may cause a response confirmation signal to be sent to processing circuitry 80 and / or processing circuitry 202. For example, a responder may initiate or cause a response confirmation signal to be sent by a respective connected portable treatment device to response network controller 24, and in turn, from response network controller 24 to processing circuitry 80 and / or processing circuitry 202.

[0095] If processing circuitry 80 and / or processing circuitry 202 determines that the response confirmation signal has been received (YES of 412), processing circuitry 80 and / or processing circuitry 202 may further control transmission of a cessation signal to response network 14 (or to response network controller 24) (414). Thus, the cessation signal indicative of the confirmation of the response to the acute health event may be generated in response to receiving, from response network controller 24, a response confirmation signal. If processing circuitry 80 and / or processing circuitry 202 determines that the response confirmation signal has not been received (NO of 412), processing circuitry 80 and / or processing circuitry 202 may continue transmitting the alert (406).

[0096] The determining termination or retraction of the acute health event (408), the determining receipt of the response confirmation signal (412), and transmission of the cessation signal (414) are each optional. In some examples, the technique of FIG. 7 may not include one or more of decisions or steps 408, 410, or 412. For example, the technique of FIG. 7 may end with transmitting the alert to response network 14 (406), or at transportation of the connected portable treatment device to the location of patient 4 (410), with blocks 408, 410, and 414 omitted or bypassed.

[0097] FIG. 8A is a perspective drawing illustrating an IMD 10A, which may be an example configuration of IMD 10 of FIGS. 1A and 2 as an ICM. In the example shown in FIG. 8A, IMD 10A may be embodied as a monitoring device having housing 512, proximal electrode 516A and distal electrode 516B. Housing 512 may further comprise first major surface 514, second major surface 518, proximal end 520, and distal end 522. Housing 512 encloses electronic circuitry located inside the IMD 10A and protects the circuitry contained therein from body fluids. Housing 512 may be hermetically sealed and configured for subcutaneous implantation. Electrical feedthroughs provide electrical connection of electrodes 516A and 516B.

[0098] In the example shown in FIG. 8 A, IMD 10A is defined by a length L, a width W and thickness or depth D and is in the form of an elongated rectangular prism wherein the length L is much larger than the width W, which in turn is larger than the depth D. In one example, the geometry of the IMD 10A - in particular a width W greater than the depth D - is selected to allow IMD 10A to be inserted under the skin of the patient using a minimally invasive procedure and to remain in the desired orientation during insertion. For example, the device shown in FIG. 8A includes radial asymmetries (notably, the rectangular shape) along the longitudinal axis that maintains the device in the proper orientation following insertion. For example, the spacing between proximal electrode 516A and distal electrode 516B may range from 5 millimeters (mm) to 55 mm, 30 mm to 55 mm, 35 mm to 55 mm, and from 40 mm to 55 mm and may be any range or individual spacing from 5 mm to 60 mm. In addition, IMD 10A may have a length L that ranges from 30 mm to about 70 mm. In other examples, the length L may range from 5 mm to 60 mm, 40 mm to 60 mm, 45 mm to 60 mm and may be any length or range of lengths between about 30 mm and about 70 mm. In addition, the width W of major surface 14 may range from 3 mm to 15, mm, from 3 mm to 10 mm, or from 5 mm to 15 mm, and may be any single or range of widths between 3 mm and 15 mm. The thickness of depth D of IMD 10A may range from 2 mm to 15 mm, from 2 mm to 9 mm, from 2 mm to 5 mm, from 5 mm to 15 mm, and may be any single or range of depths between 2 mm and 15 mm. In addition, IMD 10A according to an example of the present disclosure is has a geometry and size designed for ease of implant and patient comfort. Examples of IMD 10A described in this disclosure may have a volume of three cubic centimeters (cm) or less, 1.5 cubic cm or less or any volume between three and 1.5 cubic centimeters.

[0099] In the example shown in FIG. 8A, once inserted within the patient, the first major surface 514 faces outward, toward the skin of the patient while the second major surface 518 is located opposite the first major surface 514. In addition, in the example shown in FIG. 8A, proximal end 520 and distal end 522 are rounded to reduce discomfort and irritation to surrounding tissue once inserted under the skin of the patient. IMD 10A, including instrument and method for inserting IMD 10 is described, for example, in U.S. Patent Publication No. 2014 / 0276928, incorporated herein by reference in its entirety.

[0100] Proximal electrode 516A is at or proximate to proximal end 520, and distal electrode 516B is at or proximate to distal end 522. Proximal electrode 516A and distalelectrode 516B are used to sense cardiac EGM signals, e.g., ECG signals, thoracically outside the ribcage, which may be sub-muscularly or subcutaneously. Cardiac signals may be stored in a memory of IMD 10A, and data may be transmitted via integrated antenna 530A to another device, which may be another implantable device or an external device, such as external device 512. In some examples, electrodes 516A and 516B may additionally or alternatively be used for sensing any bio-potential signal of interest, which may be, for example, an EGM, EEG, EMG, or a nerve signal, or for measuring impedance, from any implanted location.

[0101] In the example shown in FIG. 8 A, proximal electrode 516A is at or in close proximity to the proximal end 520 and distal electrode 516B is at or in close proximity to distal end 522. In this example, distal electrode 516B is not limited to a flattened, outward facing surface, but may extend from first major surface 514 around rounded edges 524 and / or end surface 526 and onto the second major surface 518 so that the electrode 516B has a three-dimensional curved configuration. In some examples, electrode 516B is an uninsulated portion of a metallic, e.g., titanium, part of housing 512.

[0102] In the example shown in FIG. 8 A, proximal electrode 516A is located on first major surface 514 and is substantially flat, and outward facing. However, in other examples proximal electrode 516A may utilize the three dimensional curved configuration of distal electrode 516B, providing a three dimensional proximal electrode (not shown in this example). Similarly, in other examples distal electrode 516B may utilize a substantially flat, outward facing electrode located on first major surface 514 similar to that shown with respect to proximal electrode 516A.

[0103] The various electrode configurations allow for configurations in which proximal electrode 516A and distal electrode 516B are located on both first major surface 514 and second major surface 518. In other configurations, such as that shown in FIG.8 A, only one of proximal electrode 516A and distal electrode 516B is located on both major surfaces 514 and 518, and in still other configurations both proximal electrode 516A and distal electrode 516B are located on one of the first major surface 514 or the second major surface 518 (e.g., proximal electrode 516A located on first major surface 514 while distal electrode 516B is located on second major surface 518). In another example, IMD 10A may include electrodes on both major surface 514 and 518 at or near the proximal and distal ends of the device, such that a total of four electrodes are included on IMD 10A.Electrodes 516A and 516B may be formed of a plurality of different types of biocompatible conductive material, e.g. stainless steel, titanium, platinum, iridium, or alloys thereof, and may utilize one or more coatings such as titanium nitride or fractal titanium nitride.

[0104] In the example shown in FIG. 8A, proximal end 520 includes a header assembly 528 that includes one or more of proximal electrode 516A, integrated antenna 530A, anti-migration projections 382, and / or suture hole 534. Integrated antenna 530A is located on the same major surface (i.e., first major surface 514) as proximal electrode 516A and is also included as part of header assembly 528. Integrated antenna 530A allows IMD 10A to transmit and / or receive data. In other examples, integrated antenna 530A may be formed on the opposite major surface as proximal electrode 516A, or may be incorporated within the housing 512 of IMD 10A. In the example shown in FIG. 8A, anti-migration projections 532 are located adjacent to integrated antenna 530A and protrude away from first major surface 514 to prevent longitudinal movement of the device. In the example shown in FIG. 8A, anti-migration projections 532 include a plurality (e.g., nine) small bumps or protrusions extending away from first major surface 514. As discussed above, in other examples anti-migration projections 532 may be located on the opposite major surface as proximal electrode 516A and / or integrated antenna 530A. In addition, in the example shown in FIG. 8A, header assembly 528 includes suture hole 534, which provides another means of securing IMD 10A to the patient to prevent movement following insertion. In the example shown, suture hole 534 is located adjacent to proximal electrode 516A. In one example, header assembly 528 is a molded header assembly made from a polymeric or plastic material, which may be integrated or separable from the main portion of IMD 10 A.

[0105] FIG. 8B is a perspective drawing illustrating another IMD 10B, which may be another example configuration of IMD 10 from FIGS. 1A and 2 as an ICM. IMD 10B of FIG. 8B may be configured substantially similarly to IMD lOA of FIG. 8A, with differences between them discussed herein.

[0106] IMD 10B may include a leadless, subcutaneously-implantable monitoring device, e.g. an ICM. IMD 10B includes housing having a base 540 and an insulative cover 542. Proximal electrode 516C and distal electrode 516D may be formed or placed on an outer surface of cover 542. Various circuitries and components of IMD 10B, e.g.,described above with respect to FIG. 2, may be formed or placed on an inner surface of cover 542, or within base 540. In some examples, a battery or other power source of IMD 10B may be included within base 540. In the illustrated example, antenna 530B is formed or placed on the outer surface of cover 542, but may be formed or placed on the inner surface in some examples. In some examples, insulative cover 542 may be positioned over an open base 540 such that base 540 and cover 542 enclose the circuitries and other components and protect them from fluids such as body fluids. The housing including base 540 and insulative cover 542 may be hermetically sealed and configured for subcutaneous implantation.

[0107] Circuitries and components may be formed on the inner side of insulative cover 542, such as by using flip-chip technology. Insulative cover 542 may be flipped onto a base 540. When flipped and placed onto base 540, the components of IMD 10B formed on the inner side of insulative cover 542 may be positioned in a gap 544 defined by base 540. Electrodes 516C and 516D and antenna 530B may be electrically connected to circuitry formed on the inner side of insulative cover 542 through one or more vias (not shown) formed through insulative cover 542. Insulative cover 542 may be formed of sapphire (i.e., corundum), glass, parylene, and / or any other suitable insulating material. Base 540 may be formed from titanium or any other suitable material (e.g., a biocompatible material). Electrodes 516C and 516D may be formed from any of stainless steel, titanium, platinum, iridium, or alloys thereof. In addition, electrodes 516C and 516D may be coated with a material such as titanium nitride or fractal titanium nitride, although other suitable materials and coatings for such electrodes may be used.

[0108] In the example shown in FIG. 8B, the housing of IMD 10B defines a length L, a width W and thickness or depth D and is in the form of an elongated rectangular prism wherein the length L is much larger than the width W, which in turn is larger than the depth D, similar to IMD 10A of FIG. 8 A. For example, the spacing between proximal electrode 516C and distal electrode 516D may range from 5 mm to 50 mm, from 30 mm to 50 mm, from 35 mm to 45 mm, and may be any single spacing or range of spacings from 5 mm to 50 mm, such as approximately 40 mm. In addition, IMD 10B may have a length L that ranges from 5 mm to about 70 mm. In other examples, the length L may range from 30 mm to 70 mm, 40 mm to 60 mm, 45 mm to 55 mm, and may be any single length or range of lengths from 5 mm to 50 mm, such as approximately 45 mm. In addition, thewidth W may range from 3 mm to 15 mm, 5 mm to 15 mm, 5 mm to 10 mm, and may be any single width or range of widths from 3 mm to 15 mm, such as approximately 8 mm. The thickness or depth D of IMD 10B may range from 2 mm to 15 mm, from 5 mm to 15 mm, or from 3 mm to 5 mm, and may be any single depth or range of depths between 2 mm and 15 mm, such as approximately 4 mm. IMD 10B may have a volume of three cubic centimeters (cm) or less, or 1.5 cubic cm or less, such as approximately 1.4 cubic cm.

[0109] In the example shown in FIG. 8B, once inserted subcutaneously within the patient, outer surface of cover 542 faces outward, toward the skin of the patient. In addition, as shown in FIG. 8B, proximal end 546 and distal end 548 are rounded to reduce discomfort and irritation to surrounding tissue once inserted under the skin of the patient. In addition, edges of IMD 10B may be rounded.

[0110] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module, unit, or circuit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units, modules, or circuitry associated with, for example, a medical device.

[0111] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware -based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0112] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specificintegrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” or “processing circuitry” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0113] Various examples have been described. These and other examples are within the scope of the following claims.

[0114] Example 1. A system comprising: processing circuitry; and memory comprising program instructions that, when executed by the processing circuitry, cause the processing circuitry to: receive a message transmitted from a medical device, the message indicative of an acute health event of a patient detected by the medical device; and in response to the message: determine a location of the patient; generate an alert indicative of the location and the acute health event of the patient; and control transmission of the alert to a response network controller, wherein the response network controller is configured to, in response to the alert, determine a plurality of connected portable treatment devices of a response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices.

[0115] Example 2. The system of Example 1, wherein the alert is further indicative of an onset time or an elapsed time of the acute health event.

[0116] Example 3. The system of Examples 1 or 2, wherein the message comprises physiological data of the patient collected by the medical device, and wherein the alert is further indicative of at least a portion of the physiological data.

[0117] Example 4. The system of any of Examples 1 to 3, wherein the processing circuitry is further configured to generate treatment instructions based on the acute health event, and wherein the alert is further indicative of the treatment instructions.

[0118] Example 5. The system of any of Examples 1 to 4, wherein the alert is further indicative of a presence of a connected portable treatment device of the plurality of connected portable treatment devices at the location of the patient.

[0119] Example 6. The system of any of Examples 1 to 5, wherein the program instructions, when executed by the processing circuitry, further cause the processing circuitry to determine a candidate response area based on the location of the patient, and wherein the alert is further indicative of the candidate response area.

[0120] Example 7. The system of any of Examples 1 to 6, wherein the medical device comprises an implantable medical device or a wearable medical device.

[0121] Example 8. The system of Example 7, wherein the implantable medical device comprises an implantable cardiac monitor.

[0122] Example 9. The system of any of Example 1 to 8, wherein the processing circuitry comprises processing circuitry of a computing device of the patient configured to wirelessly communicate with the medical device.

[0123] Example 10. The system of Example 9, wherein the computing device of the patient comprises at least one of a smartphone, smartwatch, smart appliance, or an Internet of Things device.

[0124] Example 11. The system of any one of Examples 1 to 10, wherein the acute health event comprises at least one of a cardiac arrest, a ventricular fibrillation, a ventricular tachycardia, a myocardial infarction, a stroke, a seizure, or a fall.

[0125] Example 12. The system of any one of Examples 1 to 11, wherein at least one connected portable treatment devices of the plurality of connected portable treatment devices comprises an automated external defibrillator (AED).

[0126] Example 13. The system of any of Examples 1 to 12, wherein the program instructions, when executed by the processing circuitry, further cause the processing circuitry to control transmission of the alert to one or more computing devices of one or more caregivers or family members of the patient.

[0127] Example 14. The system of any of Examples 1 to 13, wherein the program instructions, when executed by the processing circuitry, further cause the processing circuitry to control transmission of a cessation signal to the response network controller, wherein the cessation signal is indicative of at least one of a confirmation of a response to the acute health event, a termination of the acute health event, or a retraction of the acute health event.

[0128] Example 15. The system of any of Examples 1 to 14, wherein the response network controller is further configured to, in response to the alert, transmit an emergency signal to an emergency medical services provider.

[0129] Example 16. An implantable cardiac monitor comprising: a housing; at least one electrode secured to the housing and configured to sense at least one physiological signal of a patient; processing circuitry; and memory comprising programinstructions that, when executed by the processing circuitry, cause the processing circuitry to: detect an acute health event based on the at least one physiological signal; and generate a message indicative of an acute health event of a patient detected by the medical device; and transmit the message to a system configured to generate an alert indicative of a location and the acute health event of the patient, wherein the system is further configured to control transmission of the alert to a response network controller, and wherein the response network controller is configured to, in response to the alert, determine a plurality of connected portable treatment devices of a response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices.

[0130] Example 17. The implantable cardiac monitor of Example 16, wherein the housing comprises a battery.

[0131] Example 18. The implantable cardiac monitor of Examples 16 or 17, wherein the housing defines a length L in a range from 30 mm to 70 mm, a width W in a range from 3 mm to 15 mm, and a thickness D in a range from 2 mm to 15 mm.

[0132] Example 19. A method of operating processing circuitry of a medical device system comprising: receiving, by the processing circuitry, a message transmitted from a medical device, the message indicative of an acute health event of a patient detected by the medical device; and in response to the message: determining, by the processing circuitry, a location of the patient; generating, by the processing circuitry, an alert indicative of the location and the acute health event of the patient; and controlling, by the processing circuitry, transmission of the alert to a response network controller, wherein the response network controller is configured to, in response to the alert, determine a plurality of connected portable treatment devices of a response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices.

[0133] Example 20. The method of Example 19, wherein the alert is further indicative of an onset time or an elapsed time of the acute health event.

[0134] Example 21. The method of Examples 19 or 20, wherein the message comprises physiological data of the patient collected by the medical device, and wherein the alert is further indicative of at least a portion of the physiological data.

[0135] Example 22. The method of any of Examples 19 to 21, further comprising, by the processing circuitry, generating treatment instructions based on the acute health event, wherein the alert is further indicative of the treatment instructions.

[0136] Example 23. The method of any of Examples 19 to 22, wherein the alert is further indicative of a presence of a connected portable treatment device of the plurality of connected portable treatment devices at the location of the patient.

[0137] Example 24. The method of any of Examples 19 to 23, further comprising, by the processing circuitry, determining a candidate response area based on the location of the patient, wherein the alert is further indicative of the candidate response area.

[0138] Example 25. The method of any one of Examples 19 to 24, wherein the acute health event comprises at least one of a cardiac arrest, a ventricular fibrillation, a ventricular tachycardia, a myocardial infarction, a stroke, a seizure, or a fall.

[0139] Example 26. The method of any one of Examples 19 to 25, wherein at least one connected portable treatment devices of the plurality of connected portable treatment devices comprises an automated external defibrillator (AED).

[0140] Example 27. The method of any of Examples 19 to 26, further comprising, by the processing circuitry, controlling transmission of the alert to one or more computing devices of one or more caregivers or family members of the patient.

[0141] Example 28. The method of any of Examples 19 to 27, further comprising, by the processing circuitry, controlling transmission of a cessation signal to the response network controller, wherein the cessation signal is indicative of at least one of a confirmation of a response to the acute health event, a termination of the acute health event, or a retraction of the acute health event.

[0142] Example 29. The method of Example 28, further comprising, by the processing circuitry, generating the cessation signal indicative of the confirmation of the response to the acute health event in response to receiving, from the response network controller, a response confirmation signal.

[0143] Example 30. The method of any of Examples 19 to 29, further comprising, in response to the treatment request signal, transporting at least one connected portable treatment device of the plurality of connected portable treatment devices to thelocation of the location and administering treatment to the patient with the at least one connected portable treatment device.

[0144] Example 31. A system comprising processing circuitry configured to perform the method of any of Examples 19-29.

[0145] Example 32. A non-transitory computer readable storage medium comprising program instructions configured to cause processing circuitry to perform the method of any of Examples 19-29.

Claims

CLAIMS1. A system comprising: processing circuitry; and memory comprising program instructions that, when executed by the processing circuitry, cause the processing circuitry to: receive a message transmitted from a medical device, the message indicative of an acute health event of a patient detected by the medical device; and in response to the message: determine a location of the patient; generate an alert indicative of the location and the acute health event of the patient; and control transmission of the alert to a response network controller, wherein the response network controller is configured to, in response to the alert, determine a plurality of connected portable treatment devices of a response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices.

2. The system of claim 1, wherein the alert is further indicative of an onset time or an elapsed time of the acute health event.

3. The system of claims 1 or 2, wherein the message comprises physiological data of the patient collected by the medical device, and wherein the alert is further indicative of at least a portion of the physiological data.

4. The system of any one of claims 1 to 3, wherein the processing circuitry is further configured to generate treatment instructions based on the acute health event, and wherein the alert is further indicative of the treatment instructions.

5. The system of any one of claims 1 to 4, wherein the alert is further indicative of a presence of a connected portable treatment device of the plurality of connected portable treatment devices at the location of the patient.

6. The system of any one of claims 1 to 5, wherein the program instructions, when executed by the processing circuitry, further cause the processing circuitry to determine a candidate response area based on the location of the patient, and wherein the alert is further indicative of the candidate response area.

7. The system of any one of claims 1 to 6, wherein the medical device comprises an implantable medical device or a wearable medical device.

8. The system of claim 7, wherein the implantable medical device comprises an implantable cardiac monitor.

9. The system of any one of claims 1 to 8, wherein the processing circuitry comprises processing circuitry of a computing device of the patient configured to wirelessly communicate with the medical device.

10. The system of any one of claims 1 to 9, wherein the acute health event comprises at least one of a cardiac arrest, a ventricular fibrillation, a ventricular tachycardia, a myocardial infarction, a stroke, a seizure, or a fall.

11. The system of any one of claims 1 to 10, wherein at least one connected portable treatment devices of the plurality of connected portable treatment devices comprises an automated external defibrillator (AED).

12. An implantable cardiac monitor comprising: a housing; at least one electrode secured to the housing and configured to sense at least one physiological signal of a patient; processing circuitry; and memory comprising program instructions that, when executed by the processing circuitry, cause the processing circuitry to: detect an acute health event based on the at least one physiological signal; andgenerate a message indicative of an acute health event of a patient detected by the medical device; and transmit the message to a system configured to generate an alert indicative of a location and the acute health event of the patient, wherein the system is further configured to control transmission of the alert to a response network controller, and wherein the response network controller is configured to, in response to the alert, determine a plurality of connected portable treatment devices of a response network based on the location and transmit a treatment request signal to the plurality of connected portable treatment devices.

13. The implantable cardiac monitor of claim 12, wherein the housing comprises a battery.

14. The implantable cardiac monitor of claims 12 or 13, wherein the housing defines a length L in a range from 30 mm to 70 mm, a width W in a range from 3 mm to 15 mm, and a thickness D in a range from 2 mm to 15 mm.

15. The implantable cardiac monitor of any one of claims 12 to 14, wherein the alert is further indicative of an onset time or an elapsed time of the acute health event.

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